The present invention relates to a high-sterility and high-capacity connector for lines for outflow from bottles containing fluid-liquid substances for medical use.
Connectors for outflow lines, used to extract liquid or solid drugs to be administered to patients from their containment bottles, have long been known in the medical field.
These conventional connectors substantially consist of an elongated prism-shaped body having, at its end, a hollow tip or piercing element by means of which, after being pushed firmly by an operator, it penetrates the closure of the bottles, which is conveniently made of elastic material in order to ensure a hydraulic and sterile seal, and directly connects the drug to the outflow line, being equipped with all the administration adjustment devices, such as flow control elements, fastening clamps, filters, additional access ports, et cetera.
One of the most widely occurring problems relates to maintaining the sterility of the entire administration line, which is made of single-use material. This sterility is attacked from outside and endangered by the maneuvers required to provide the connection: the bottle and its closure are preserved in the atmosphere, and the piercing element, after tearing the sterile packaging that protects the connector, is necessarily placed in contact with it and thus becomes a vehicle for conveying bacteria of all kinds, which reach the drug stored inside and, ultimately, the patient.
A second drawback is the limited capacity that conventional connectors allow to achieve.
The passage section for the outflowing drug is in fact substantially limited, and therefore operators, if necessary, resort to fully removing the closure of the bottles in order to be able to have, when required, a significantly higher capacity, particularly in the case of viscous liquids such as e.g. contrast liquids for imaging-based diagnostics.
This entails removing from the bottle, with troublesome maneuvers and possibly by using makeshift tools which as such are dangerous for the safety of the operators who risk injuring themselves, first the metal collar that holds the closure in place and then the closure itself, leaving the mouth of the bottle fully unprotected from contamination.
A third drawback is the intentional or accidental possibility of reusing a same connector more than once and for a plurality of drugs, violating the specific strictly single-use characteristics for which such connectors are manufactured and marketed, since in conventional connectors there is no provision to avoid this possibility.
The aim of the present invention is to solve the above-noted drawbacks of the prior art by providing a high-sterility and high-capacity connector for lines for outflow from bottles for containing fluid-liquid substances for medical use which allows to keep the field of action of the entire outflow line as sterile as possible, despite the maneuvers required in order to provide connection to the bottles, allows to increase satisfactorily the capacity if required, and finally is absolutely not reusable after its first use.
This aim and other objects, which will become better apparent hereinafter, are achieved by a high-sterility and high-capacity connector for lines for outflow from bottles for containing fluid-liquid substances for medical use, characterized in that it comprises an elongated cylindrical body having, in a lower portion thereof an anatomically shaped grip portion and at an upper end thereof a protruding piercing element being functionally combined with means for engaging a rim of the neck of the bottle.